Contraceptive Device; ComplicationsPhase 2contraceptionNCT06203080
The Contraceptive Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women.
A Phase 2 study testing ancetate gel and nonoxinol gel in people with Contraceptive Device; Complications, run by National Research Institute for Family Planning, China at 4 sites in China.
Trial summary
The study aims to explore the efficacy and safety of an intravaginal acetic acid thermoreversible gel in Chinese women of reproductive age, comparing it with nonoxinol gel by assessing the six-month Pearl Index and the incidence of any side effects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Device; Complications
- What is being tested?
- ancetate gel and nonoxinol gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2024to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Aged between 20 and 45 years old;
- 2) Regular menstrual cycles (cycle length 25-35 days, menstruation lasting up to 7 days);
- 3) Have a history of pregnancy with the current partner at least once;
- 4) Currently engaging in regular sexual activity and planning to do so in the next six months (at least once a week);
- 5) Have not used hormonal contraceptive methods in the past 3 months;
- 6) Normal menstrual cycles have resumed after the removal of an intrauterine device;
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- 7) Normal menstrual cycles have resumed after a previous miscarriage;
- 8) Breastfeeding women with normal menstrual cycles resumed;
- 9) No apparent gynecological abnormalities confirmed through examination, and normal cervical cytology (Pap smear grade I according to the Bethesda system);
- 10) Reliance on the investigational drug as the sole contraceptive method during the study period;
- 11) Willing to participate in this study, adhere to required follow-up visits, and voluntarily sign the informed consent form.
Who cannot join
- 1) Amenorrhoea for more than 1 month, suspected pregnancy;
- 2) Moderate to severe erosive changes in the cervix;
- 3) Vaginal cleanliness grade III or above;
- 4) Trichomonas, fungal vaginitis, and bacterial vaginosis, among other conditions, have not been cured;
- 5) Uterine prolapse of degree II or above and severe protrusion of the anterior and posterior vaginal walls;
- 6) Unexplained vaginal bleeding;
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- 7) Genital tract deformities;
- 8) Malignant tumors of the genital tract;
- 9) Moderate or severe urinary incontinence;
- 10) Recurrent urinary tract infections;
- 11) History of allergy to acetic acid and/or nonoxinol.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100081
Wenpei Bai, MD, bwp66@163.com
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200433
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050004
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, 300199
About this study
Official title: The Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women of Reproductive Age Compared With Nonoxinol Gel: A Multi-central Phase II, Triple-blind, Randomized Trial
The study aims to explore the efficacy and safety of an intravaginal acetic acid thermoreversible gel in Chinese women of reproductive age, comparing it with nonoxinol gel by assessing the six-month Pearl Index and the incidence of any side effects.
Read the detailed description
Despite significant increases in the availability and effectiveness of contraceptives globally, there are few female-led devices that combine contraception and STI prevention. Previous studies suggested that acetic acid thermoreversible gel, a female targeted contraception, can regulate intravaginal ph, killing sperm and STI pathogens and protecting intravaginal probiotics. Therefore, we have developed a contraceptive gel containing 11.23 mg/g of poloxamer 407-acetic acid. To determine its contraceptive effectiveness and safety compared with the widely used nonoxinol gel, we will recruit about 240 reproductive-aged women in four centers in China and randomly allocate into two groups. During a six-month follow-up, we will compared their pregnant rates and incidence of adverse events.
- Conditions
- Contraceptive Device; Complications
- Being tested
- ancetate gel, nonoxinol gel
- Keywords
- contraception, STD
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ancetate gelDrug
An acetic acid thermoreversible gel produced by Shanghai Jinxiang Latex Products Co. will be utilized for the intervention. Each product weighs 4.85 g and contains 54.45 mg of poloxamer 407-acetic acid. The investigators will stockpile the product and distribute a total of 72 doses on the first day, at the end of the second month, and at the end of the fourth month of follow-up, respectively, after concealing the product's name. Participants will receive instructions to apply the medication transvaginally, one dose at a time, during each instance of sexual activity.
nonoxinol gelDrug
The nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be utilized for the intervention. Each product weighs 5 g and contains 50 mg of N-9. The investigators will stockpile the product and distribute a total of 72 doses on the first day, at the end of the second month, and at the end of the fourth month of follow-up, respectively, after concealing the product's name. Participants will receive instructions to apply the medication transvaginally, one dose at a time, during each instance of sexual activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | An acetic acid thermoreversible gel developed by Shanghai Jinxiang Latex Products Co. will be allocated to the intervention group. Receives: Drug: ancetate gel |
| Controlled group | Active comparator | Nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be allocated to the cotrolled group. Receives: Drug: nonoxinol gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate
Pregnancy due to contraceptive failure under correct use and pregnancy due to incorrect and or discontinuous use will be respectively observed for six months for both groups.
Measured: Six months
Pregnancy rate during three months
A cumulative incidence will be calculated according to the number of pregnancies during the first three months.
Measured: Three months
Pregnancy rate during six months
A cumulative incidence will be calculated according to the number of pregnancies during the whole six months.
Measured: Six months
Termination rate during three months
The termination due to any complications will be observed respectively in both groups during the first three months.
Measured: Three months
Termination rate during six months
The termination due to any complications will be observed respectively in both groups during the whole six months.
Measured: Six months
Secondary outcomes (5)
Complaint of adverse reactions
Complaint rates of various adverse reactions (allergy/leucorrhoea/local irritation) during different follow-up time.
Measured: Six months
Biochemical index
Biochemical index will be recorded respectively at the beginning of the follow-up and at the end of the follow-up through blood routine, urinalysis and liver function test.
Measured: Six months
Adherence use
Adherence use will be evaluated during the follow-up respectively at the end of the first two weeks, two months, four months and six months through checking the number of used drugs packages and unused drugs.
Measured: Six months
Concomitant drugs
Concomitant drugs will be recorded during the follow-up respectively at the end of the first two weeks, two months, four months and six months through the questionnaire.
Measured: Six months
Vaginal internal environment
Vaginal microbiota examination will be used during the follow-up respectively at the end of the first two weeks, two months, four months and six months by professional physicians to evaluate the participant's vaginal internal environment whether is suitable for continuation of the trial.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive Device; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Institute for Family Planning, China
- Sponsor type
- Other government
- Collaborators
- Shanghai Jinxiang Latex Products Co.
- Responsible party
- Sponsor
- Investigators
- Kaiyan Pei, MD, Principal investigator, National Research Institute for Family Planning, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203080
- Sponsor's protocol ID
- NRIFP2023027
- Acronym
- contraception
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women of Reproductive Age Compared With Nonoxinol Gel: A Multi-central Phase II, Triple-blind, Randomized Trial
- ClinicalTrials.gov ID
- NCT06203080
- Acronym / sponsor ID
- contraception / NRIFP2023027
- Conditions
- Contraceptive Device; Complications
- Keywords
- contraception, STD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Research Institute for Family Planning, ChinaOther government
- Collaborators
- Shanghai Jinxiang Latex Products Co.
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to explore the efficacy and safety of an intravaginal acetic acid thermoreversible gel in Chinese women of reproductive age, comparing it with nonoxinol gel by assessing the six-month Pearl Index and the incidence of any side effects.
Detailed description
Despite significant increases in the availability and effectiveness of contraceptives globally, there are few female-led devices that combine contraception and STI prevention. Previous studies suggested that acetic acid thermoreversible gel, a female targeted contraception, can regulate intravaginal ph, killing sperm and STI pathogens and protecting intravaginal probiotics. Therefore, we have developed a contraceptive gel containing 11.23 mg/g of poloxamer 407-acetic acid. To determine its contraceptive effectiveness and safety compared with the widely used nonoxinol gel, we will recruit about 240 reproductive-aged women in four centers in China and randomly allocate into two groups. During a six-month follow-up, we will compared their pregnant rates and incidence of adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: ancetate gelAn acetic acid thermoreversible gel developed by Shanghai Jinxiang Latex Products Co. will be allocated to the intervention group. |
| Controlled group | Active comparator | Drug: nonoxinol gelNonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be allocated to the cotrolled group. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 1) Aged between 20 and 45 years old;
- 2) Regular menstrual cycles (cycle length 25-35 days, menstruation lasting up to 7 days);
- 3) Have a history of pregnancy with the current partner at least once;
- 4) Currently engaging in regular sexual activity and planning to do so in the next six months (at least once a week);
- 5) Have not used hormonal contraceptive methods in the past 3 months;
Key exclusion criteria (11 listed)
- 1) Amenorrhoea for more than 1 month, suspected pregnancy;
- 2) Moderate to severe erosive changes in the cervix;
- 3) Vaginal cleanliness grade III or above;
- 4) Trichomonas, fungal vaginitis, and bacterial vaginosis, among other conditions, have not been cured;
- 5) Uterine prolapse of degree II or above and severe protrusion of the anterior and posterior vaginal walls;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ancetate gelAn acetic acid thermoreversible gel produced by Shanghai Jinxiang Latex Products Co. will be utilized for the intervention. Each product weighs 4.85 g and contains 54.45 mg of poloxamer 407-acetic acid. The investigators will stockpile the product and distribute a total of 72 doses on the first day, at the end of the second month, and at the end of the fourth month of follow-up, respectively, after concealing the product's name. Participants will receive instructions to apply the medication transvaginally, one dose at a time, during each instance of sexual activity. | Drug | Intervention group |
| nonoxinol gelThe nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be utilized for the intervention. Each product weighs 5 g and contains 50 mg of N-9. The investigators will stockpile the product and distribute a total of 72 doses on the first day, at the end of the second month, and at the end of the fourth month of follow-up, respectively, after concealing the product's name. Participants will receive instructions to apply the medication transvaginally, one dose at a time, during each instance of sexual activity. | Drug | Controlled group |
Primary outcome
Failure rate
Time frame: Six months
Pregnancy due to contraceptive failure under correct use and pregnancy due to incorrect and or discontinuous use will be respectively observed for six months for both groups.
Pregnancy rate during three months
Time frame: Three months
A cumulative incidence will be calculated according to the number of pregnancies during the first three months.
Pregnancy rate during six months
Time frame: Six months
A cumulative incidence will be calculated according to the number of pregnancies during the whole six months.
Termination rate during three months
Time frame: Three months
The termination due to any complications will be observed respectively in both groups during the first three months.
Termination rate during six months
Time frame: Six months
The termination due to any complications will be observed respectively in both groups during the whole six months.
5 secondary outcomes
Complaint of adverse reactions
Time frame: Six months
Biochemical index
Time frame: Six months
Adherence use
Time frame: Six months
Concomitant drugs
Time frame: Six months
Vaginal internal environment
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaiyan Pei, MD principal investigator
National Research Institute for Family Planning, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ancetate gel and nonoxinol gel in people with Contraceptive Device; Complications, run by National Research Institute for Family Planning, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue Jiang (+8618011490663, 2216949459@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rate (time frame: Six months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.